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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Congress Slams Third-party Food Facility Audits

A congressional report released on 10 January slammed a third-party auditor for giving a food production facility a "superior" ranking just two months before an outbreak of listeria that originated at the facility killed 30 people.

The facility, Jensen Farms, had hired Colorado-based Primus Labs to conduct the facility's audit. Congressional investigators found that the auditors were either ignorant of FDA guidance documents regarding food safety&nbsp;or blatantly ignored them.

The report calls for the US Food and Drug Administration to crack down on third-auditors, calling them "a significant gap in the food safety system".

FDA does not presently regulate third-party auditors.

The Food Safety and Modernization Act (FSMA), signed last year, provided funding to FDA to increase inspections of facilities, but the money is subject to the congressional appropriations process, and FDA's increase in funding for 2012 was roughly 1/10th of what the FDA had lobbied for.

Congressional investigators noted that Primus Labs passed as "superior" the overwhelming majority of facilities that it inspected, but company executives rejected that they were auditing companies without regard to safety regulations.

Primus executives did, however, admit to not accounting for adherence to FDA food guidance documents in their audits. FDA does not have specific regulations governing cantaloupe processing.

Congressional Democrats and Republicans differed in their reaction to the report. Democrats called for increased inspections and a crackdown on third-party auditors, while Republicans made no recommendations.